Thursday, 21 March 2013

The Department of Health (DOH) released on March 20, 2013, the implementing rules and regulations regarding stem cell and cell-based therapy in the country.

“Our efforts at regulating the practice of stem-cell therapy in this country are aimed at safeguarding the welfare of our patients and the general public by making safe, effective and ethical stem-cell modalities and practices are within emerging international and global standards considering the very complex nature of this therapy,” Secretary of Health Enrique Ona said.

DOH Administrative Order 2013-0012 (AO 2013-0012), also known as Rules and Regulations Governing the Accreditation of Health Facilities Engaging in Human Stem Cell and Cell-based or Cellular Therapies in the Philippines, is aimed at ensuring that human stem cell and cell-based therapies in the country are safe and effective for their intended use.

It also intends to prevent the introduction, transmission, and spread of communicable diseases by ensuring a minimum quality of service and staff qualification rendered by hospitals and other health facilities capable of utilizing human stem-cell preparations and cell-based therapies.

These guidelines will classify which stem-cell preparations and therapies will be registered and allowed with certain restrictions. Preparations that will be allowed include those with adult human stem cells, human umbilical cord stem cells, and human organ-specific cells.

The AO restricts the use of genetically altered stem cells and tissues of human adults and the umbilical cord, fat-derived human stem cells, and live animal stem cells; the AO also prohibits for human treatment and research the creation of human embryos and their derivatives, the use of aborted human fetal stem cells and their derivatives, and plant parts labeled as stem cells.

Health facilities utilizing stem cell preparations and cell-based or cellular therapies will be mandated to comply with the guidelines set by the Bioethics Advisory Board composed of the DOH, the National Transplant Ethics Committee, the Philippine Food and Drug Administration (FDA), a government health facility, a private organization or health facility, academicians, researchers, and local and international experts.

This Board will ensure that ethical and professional standards are upheld and that contentious scientific, ethical and legal issues are addressed. Charges and complaints shall be addressed to the DOH Bureau of Health Facilities & Services and the Philippine FDA.

Meanwhile, an Institutional Review Board will review and approve stem-cell therapies, based on the guidelines set by the Bioethics Advisory Board. There are minimum standards for personnel qualifications, physical facilities, equipment and supplies and work environment, which will be prescribed by the guidelines. Proper record keeping in each facility that will provide readily available information on each donor, patient, procedures on stem cell and cell-based therapies will be mandated as well.

DOH Administrative Order 2013-0012 takes effect 15 days after March 20, 2013, its publication date, and shall be reviewed three years after its implementation.